BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION/TELEPACK

    MDR report key: 3091586 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00159
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    August 21, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS ADVISED TO CONTACT MINDRAY SERVICE FOR FURTHER INVESTIGATION. THE SYSTEM ANTENNA MAY HAVE BEEN THE CAUSE OF THE ERROR AND THE CUSTOMER SUBSEQUENTLY REPLACED THE ANTENNA. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A TELEPACK WOULD NOT DISPLAY AT THE PANORAMA CENTRAL STATION RESULTING IN A POSSIBLE LOSS OF AMBULATORY TELEMETRY MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187388 PANORAMA CENTRAL STATION/TELEPACK CENTRAL STATION MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1